Clinical Evaluation of Different Bioactive Restorative Materials for Cervical Carious in High Caries Risk Patients

Clinical Evaluation of Different Bioactive Restorative Materials for Cervical Carious in High Caries Risk Patients :A Randomized Clinical Trial

The aim of the study is to clinically evaluate three different bioactive restorative material in cervical carious lesion in high caries risk patients.

Reducing the incidence of recurrent caries is the primary outcome

Study Overview

• Status: Enrolling by invitation
• Conditions: Class V Dental Caries; High Caries Risk Patients
• Intervention / Treatment: Device: Giomer

Detailed Description

Bioactive restorative materials are relatively new concept in dentistry combines between esthetics, strength and resilience of composites with bioactive properties, the development of therapeutic bio-interactive materials results in tissue re-mineralization, reduces the susceptibility to tooth mineral loss, and recovers its mechanical properties .

Patients, with high caries, have many risk factors like inadequate biofilm control, salivary flow deficiency, and altered host defense. Conventional restorative materials expose the tooth structure to stress concentration. Moreover, preserving the tooth restoration interface intact is great challenge to avoid recurrent caries, which may also result in restoration failures .

This prospective study will be investigating and comparing the eighteen month clinical performance of a different bioactive restorative materials and a conventional Pre-reacted glass ionomer restorative material in class V cavity preparation.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Faculty of Dentistry Cairo University, Cairo, Egypt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Patient age range from 25-45 year.
• High risk caries.
• Patients required at least a couple of Class V restorations.
• The depth of lesion should be(1.5- 2 mm) .
• The patient should have good general health

Exclusion Criteria:

• Poor oral hygiene.
• Sever or chronic periodontal disease or Bruxism.
• Severe tooth sensitivity.
• Non-vital or fracture or cracked teeth.
• Defective restorations, orthodontic treatment or bleaching procedures during the last 6 months.
• pregnancy, and/or lactation, and allergy to the main components of the products to be used in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Predicta; based on dual cure bulk fill bioactive restoration	Device: Giomer; based on Pre-reacted glass ionomer (PRG)
Experimental: Activa presto; based on Bio-glass reinforced glass Ionomer	Device: Giomer; based on Pre-reacted glass ionomer (PRG)
Active Comparator: Giomer; based on Pre-reacted glass ionomer (PRG)	Device: Giomer; based on Pre-reacted glass ionomer (PRG)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical performance (Post operative hyper sensitivity)	method of measurement is Modified United State Public Health Service Criteria (Modified USPHS) using Binary (yes/ no) yes outcome mean recurrent caries present, no mean no recurrent caries present .	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical performance (Fracture and retention, marginal integrity, marginal discoloration, anatomic form, surface texture, postoperative sensitivity)	method of measurement is Modified United State Public Health Service Criteria (Modified USPHS) using (Alpha ,Bravo, Charlie) as unite of measurement by scoring %. Alpha is best outcome and Charlie worse outcome.	18 months

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Ashraf Nasr, professor, Cairo university

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: November 25, 2024
• First Submitted That Met QC Criteria: December 13, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 13, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: bioactive restorative material; dual cure bulk fill bio-active restoration; Pre-reacted glass ionomer (PRG) Giomer
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth Demineralization; Dental Caries
• Other Study ID Numbers: Ahmed abdul monsif

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: all collected IPD will be shared with supervisor: dr.Ashraf Nasr , Dr. yahia Hafez

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes